Medical Device Malfunction - Customer Complaint - Response vs. Correction

Chrisx

Involved In Discussions
#1
When writing complaint response to customers, it is sometimes tempting to include additional information to avoid the device malfunction in the future. Is it likely that the FDA could interpret such a letter as a reportable correction under 21CFR806?
 
Elsmar Forum Sponsor
R

randomname

#2
Don't know about the FDA, but if you have to provide additional information that may indicate that either the design is weak or the instructions for use are weak, or both.
 

shimonv

Trusted Information Resource
#3
Hi Chrisx,
There are three types of recalls:
• Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Under 21 CFR 806, manufacturers and importers need not report events categorized as class III recalls under 21 CFR §7; only record keeping requirements would apply.

So, if the complaint is about a situation that is not likely to cause adverse health consequences (e.g. minor issue, routine service, normal ware) I do not think the agency will come after you or consider this as recall.

Keep in mind that your internal records - complaint investigation, risk management, etc. need to support you assessment.

Cheers,
Shimon
 
Thread starter Similar threads Forum Replies Date
C Medical Device Malfunction during misuse - Does this need to be reported to the FDA? Other US Medical Device Regulations 5
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
P Definition of "Standalone" medical device Other Medical Device Regulations World-Wide 5
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
M Medical Device AE Reporting SOP Medical Device and FDA Regulations and Standards News 0
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
S Assembling technical file for a medical device ISO 13485:2016 - Medical Device Quality Management Systems 1
K Class I Medical Device Registration EU Medical Device Regulations 11
B Telemedicine as a Medical Device EU Medical Device Regulations 4
S Definition of disease as per medical device defintion EU Medical Device Regulations 14
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
A What activities are included in the action of marketing you medical device in U.S.? Medical Device and FDA Regulations and Standards News 1
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
R Class II Active Medical Device SYSTEMS and COMPONENTS Canada Medical Device Regulations 2
B Rework of a medical device EU regulations EU Medical Device Regulations 5
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
somashekar Medical device file Vs Role undertaken by the organization ISO 13485:2016 - Medical Device Quality Management Systems 1
M Medical Device Label - Language EU Medical Device Regulations 2
D MDR: Active medical device or not? Medical Information Technology, Medical Software and Health Informatics 14
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 2
T Classification Accessory Software medical device EU Medical Device Regulations 4
J CGMP Medical device slide deck Manufacturing and Related Processes 1
M Notification Requirements for Medical Device Raw Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Madagascar medical device regulation Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom